Investigator Initiated Studies – Series of Webinars
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About this course
Reasons to attend
Investigator Initiated Studies (IIS) are crucial for new product development.These Investigator Initiated Studies represent new challenges for the Investigators and their team. Indeed, managing a Clinical Trial as sponsor is outside of their day-to-day work. This Investigator Initiated Studies training programme is intended to help them understanding how to implement mandatory Clinical Studies rules for sponsor in practice in order to ensure patient safety and data quality and overcome all challenges associated to it. If you want to have a clear overview of the IIS set-up and management specificities, then this course is for you!What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course schedule
- Live online training: 14 webinars (1.5h to 2h each)
Course Description
A large proportion of clinical Studies are conducted by (non-commercial) sponsor-investigators. Non-commercial sponsor-investigators rely on funding which comes partly or entirely from public funds or charities. These limited resources (team and fund) represent challenges and specificities in the Clinical Trial implementation and management. Moreover, the non-commercial sponsor is required to understand the division of responsibilities and requirements. ECCRT developed this Investigator Initiated Studies training in order to help them to maximise their valuable contribution as non-commercial sponsors without compromising the quality of clinical Studies.This course is covering how to set-up and how to manage a clinical trial in this specific context at all operational level e.g. data management, budget management, monitoring, safety, quality etc. After this course attendees will have a clear understanding about the challenges it represents to implement a study as a sponsor-investigator and how to overcome them in order to ensure patient safety and data quality as requested by ICH-GCP. This course will allow attendees as well to share their experience and questions with their peers, trainers and one field expert.Find out more in our flyer: IIS flyer.Programme highlight
The programme on Investigator Initiated Studies training consists of a series of 14 webinars of 1-2 hours each. The webinars will be live, to encourage interaction between the subject matter experts and the audience. All sessions will be recorded and available on the ECCRT Virtual Campus, in case you have missed one.
- Session 1: What is the role and responsibilities of a Sponsor-Investigator? – 2h
- Session 2: How to write a Protocol and an Informed Consent to obtain EC approval? – 2h
- Session 3: Why do we need Statistics in Clinical Trials – 1.5h
- Session 4: What type of contracts do I need to put in place? – 2h
- Session 5: How to obtain Ethics committee (EC) and Competent Authorities (CA) approval? – 1.5h
- Session 6: What is the role of the Sponsor-Investigator in the data collection? - 1.5h
- Session 7: Why do I need quality management system? – 1.5h
- Session 8: What is the Trial Master file (TMF)? – 1.5h
- Session 9: What is trial management for a Sponsor-Investigator? - 2h
- Session 10: What are the challenges in budget management for Investigator Initiated Trials? – 2h
- Session 11: What needs to be monitored and reported regarding patient’s safety? - 1.5h
- Session 12: How do I fulfil the ICH-GCP requirements regarding monitoring? – 2h
- Session 13: How to write a Clinical Study report (CSR)? - 1.5h
- Session 14: What’s next? – 1h
Learning objectives
General:
- Recognise the difference between Investigator Initiated Trials and commercial studies.
- Understand the specificities of non-commercial clinical research in term of set-up, management and regulatory requirements
- Recognise challenges and solutions for proper management & documentation of sponsor-investigator studies
- Being able to act and guide a team in setting up an own Investigator Initiated Trial
- Be able to make the difference with commercial Studies and Investigator Initiated Studies
- Describe the role and responsibilities of an Investigator within Investigator Initiated Studies
- Describe what are the key elements to be considered when writing a protocol
- Understand what Quality by Design is
- Know how to calculate a sample size
- Describe the key elements of a clinical trial statistical analysis
- Describe the different type of contracts
- Explain the key elements of a Clinical Trial Agreement
- Describe the role and responsibilities in submission to Ethics Committee and Competent Authorities
- Identify key element to obtain study approval
- Describe the role of the Investigator acting as a Sponsor in quality management
- Define the key elements to be Inspection ready
- Describe the role of the Investigator acting as a Sponsor in quality management
- Define the key elements to be Inspection ready
- Know the TMF content
- Explain why TMF is essential in the study quality
- Identify key elements in study management of an IIS
- Define what is study oversight
- Describe how to obtain budget
- Identify the key elements in budget preparation and control
- Describe the Investigator responsibilities in safety monitoring
- Understand how to set up an Independent Data Monitoring Committee (IDMC)
- Explain what and how to report safety events to Competent Authorities
- Explain the role of monitoring in data quality
- Be able to set-up monitoring activities in Investigator Initiated Studies
- Have a basic understanding of the impact of GDPR when running investigator Initiated Studies
- Describe what the content of a Clinical Study report is
- Be able to oversee the writing and submission of a Clinical Study Report
- Understand reporting requirements and timelines
- Get insights on new trends in Clinical Studies and their management
- Trigger action planning for carrying out own Investigator Initiated Studies
Who should attend
Investigational site staff, Investigators, and PhD students that are (starting to get) involved in running Investigator Initiated Studies and who want to have a clear understanding of the responsibilities as a sponsor and how to implement clinical trial rules as a sponsor-investigator in their day-to-day practice.
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (0)
- Investigational Product Development and Regulation (3)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (0)
- Data Management and Informatics (0)
- Leadership and Professionalism (0)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Trainers
Dr. Paula Hemdal
Trainer
Mr. Olivier Van Obberghen
Trainer
Dr. Roman Bobrovsky
Trainer
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